ocal treatment in addition to endocrine therapy in ER-positive/HER2-negative oligo-metastatic breast cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0003767
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 110
Age: = 19 years
- Sex: Female
- ER- positive/HER2-negative breast cancer patients, who were diagnosed with metastatic recurrence after primary treatment(surgery +/-, radiotherapy, neoadjuvant or adjuvant chemotherapy, adjuvant hormone therapy) for more than one year.
- Oligometastases: = 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)
- If the metastatic lesion count is different in patients who have performed two or more imaging test, more will be the result of the suspected imaging.
- Metastatic lesions are up to 3 cm or less.
- Lung : lesion within one side
- Liver: lesion within single lobe
- Lymph node : lesion with no more than two metastatic lymph node as mediastinum or opposite axilla, supraclavicular node and neck.
Confirmed by a biopsy
Two or more imaging test suspect metastasis
- Metastatic lesions are feasible for loco-regional therapy (resection, radiotherapy, or radiofrequency ablation) (size=3cm)
- Patients who are able to communicate without problems with obtaining consent related to the clinical trial
- Excludes patients who have any of the following criteria:
- Multiple metastatis (3 or more metastatic lesions within a single organ, 2 or more metastatic organs)
- In case local treatment(resection, radiotherapy, or radiofrequency ablation) is not possible even if there are two or fewer lesions within a organ
- Patients with other primary cancer (except thyroid cancer and melanoma)
- Pregnancy and lactating women
- Unable to read consent form (ex:illiterate, foreigner etc.)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival